Synopsis

For the OCTAVE Induction trials (1 and 2), eligible patients had moderate–severe UC (Mayo score 6–12 with endoscopic subscore 2–3) and had failed or had adverse events to one of the following: steroids, immunosuppressants, infliximab, or adalimumab. Permitted adjuvant therapies were oral 5-ASA or prednisone (25 mg/d or less) at stable doses during induction. Patients were randomized 4:1 to tofacitinib (10 mg bid) or placebo for 8 weeks. Patients were then invited to participate in the OCTAVE Sustain trial if they had a clinical response defined as a 3-point reduction in baseline Mayo (and 30% overall) and improvement by 1 point in rectal bleeding. Patients were randomized 1:1:1 to tofacitinib twice daily at 5 mg or 10 mg or placebo until week 52. Prednisone was tapered during OCTAVE Sustain. Endoscopy was performed at weeks 0, 8, and 52. Clinical remission was the primary endpoint for both the induction and maintenance studies. Adverse events were monitored throughout.

At weeks 8 and 52, patients receiving tofacitinib had significantly higher rates of remission (Table 1) and mucosal healing. During Sustain at week 52, tofacitinib at the higher dose also increased mucosal healing (37.4% vs. 45.7%) versus placebo (13.1%). Adverse and severe adverse events were similar across the trials except that patients receiving the study drug had more changes in cholesterol profile and more episodes of non-serious infection (including herpes Zoster).

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